| Primary Device ID | 00841517102265 |
| NIH Device Record Key | f7a4d8d5-8090-467e-95f1-cce1da1eb14e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HFL38xi/13-6 MH, armored |
| Version Model Number | P20377-10A |
| Catalog Number | P20377 |
| Company DUNS | 014438860 |
| Company Name | FUJIFILM SONOSITE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(999)999-9999 |
| xyz@xyz.com |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841517102265 [Primary] |
| ITX | Transducer, ultrasonic, diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-28 |
| Device Publish Date | 2017-06-22 |
| 00841517110796 - L15-4 | 2024-11-04 Diagnostic ultrasound system |
| 00841517110802 - L15-4 | 2024-11-04 Diagnostic ultrasound system |
| 00841517110758 - Sonosite PX | 2024-10-02 Diagnostic ultrasound system |
| 00841517110765 - SonoSite LX | 2024-10-02 Diagnostic ultrasound system |
| 00841517110789 - Sonosite ST | 2024-10-02 Diagnostic Ultrasound System |
| 00841517110604 - C5-1 | 2024-09-04 Diagnostic ultrasound system |
| 00841517110611 - L19-5 | 2024-09-04 Diagnostic ultrasound system |
| 00841517110628 - P5-1 | 2024-09-04 Diagnostic ultrasound system |